1. Field of the Invention
The present invention concerns the field of uterine manipulators and, more particularly, to such a manipulator including a multi-functional cup-shaped shield having an open front and which is multifunctional to protect the outer uterine wall from trauma, provide means for manipulating and retracting the uterus in all directions, and also seal the uterine cavity.
2. Description of the Relevant Prior Art
There are a variety of prior art uterine manipulators used in positioning the uterus during various surgical procedures, such as anterior and posteriorial abdominal colpotomy, total laparoscopic hysterectomy, partial laparoscopic hysterectomy, laparoscopy assisted hysterectomy, and laparoscopy assisted vaginal hysterectomy, as well as other procedures and examinations. Generally, during the performance of a laparoscopic procedure, a small incision is made in the wall of the abdomen and a laparoscope is inserted therethrough to permit visualization of the peritoneal cavity and the uterus. Uterine manipulators also frequently function as catheters for irrigating the uterine cavity, particularly during radio imaging procedures such as hysteroselpingraphy.
A number of uterine manipulators and irrigators have been developed to assist the physician in visualizing the uterus and facilitating the performance of these various examinations and procedures. See, for example, U.S. Pat. Nos. 3,926,192; 4,000,743; 4,089,337; 4,430,076; 4,775,362; 4,976,717; 4,997,419; 4,997,419; and 5,209,754. Typical of these are: U.S. Pat. No. 4,000,743, which describes a uterine anteverter which includes an arcuately curved shield which limits the distance a manipulating arm can be extended into the uterine cavity; U.S. Pat. No. 4,775,362, which describes a uterine manipulator including a catheter tube with an insertable end adapted to be inserted into the uterus, an adjustable stop adapted to engage the cervix mounted on and shiftable axially along the catheter tube, and a digitally actuated clamp which is positioned outside the external opening of the vagina with the manipulator in place; and U.S. Pat. No. 5,209,754 which describes a vaginal cervical retractor used to maneuver and visualize the uterus including an inner tube provided with a removable pair of plastic caps designed to be inserted into the uterine cavity and a cervical cap secured to the tube to ensure that the tube does not extend beyond a certain distance into the uterus. Furthermore, a rigid, metal cup shaped catheter tube is also manufactured by the Story Company, a German concern, and marked with the number 26168T.
None of the prior art medical instruments are completely satisfactory. In particular, none of them provide any shielding for the lower segment of the posterior uterine wall which extends into the vaginal posterior cul-de-sac and which, during laparoscopic surgery, is particularly vulnerable to damage from laser beams, as well as conventional surgical trauma. Moreover, it is difficult to identify the positions of the posterior cul-de-sac and the rectum, which lies behind the cul-de-sac during abdominal laparoscopic surgery, and this sometimes results in trauma to the rectum, a highly undesirable outcome. The possibility of injury to the posterior uterine wall and rectum has been noted in the literature. For example, in an article entitled "Adhesion Formation After Endoscopic Posterior Colpotomy", Journal of Reproductive Medicine, volume 38, no. 7, pp. 534-536, F. Nezhat et al. note: "Surgical entry into the posterior vagina by colpotomy does enlist the potential for significant complications. Rectal injury may occur when the rectovaginal reflector rests high upon the uterosacral hiatus." Furthermore, the prior art devices tend to be both inefficient at sealing the uterine cavity, and awkward and complicated to use. What is really needed is a simple, well designed instrument which facilitates manipulation of the uterus during surgical procedures, which helps to protect the vaginal posterior cul-de-sac wall from damage, and, optionally, effectively seals the uterine cavity. It would also be highly desirable if such a device could serve as a marker to identify the position of the posterior cul-de-sac and reduce or eliminate trauma to the rectum.